Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

Uncomplicated Plasmodium Falciparum Malaria Clinical Trial

Official title:

Rapid Diagnostic Testing and Artemisinin-Based Combination Therapy for Uncomplicated Malaria by Community Health Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301015
• Other study ID #: RapAct 28-02-2006
• Status: Completed
• Phase: Phase 4
• First received: March 8, 2006
• Last updated: October 31, 2007
• Start date: March 2006
• Est. completion date: August 2006

Study information

• Verified date: October 2007
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tanzania: Ministry of HealthSweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficiency of a rapid diagnostic test (Paracheck Pf) for the diagnosis of uncomplicated Plasmodium falciparum malaria by community health workers at village level in Tanzania and how the use of rapid diagnostic test may influence prescription of antimalarial drugs.

The hypothesis is that rapid diagnostic tests used by community health workers will reduce the use of antimalarial drugs (Coartem; Novartis) by 30% without affecting the health outcome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3005
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Fever

• Informed consent

Exclusion Criteria:

• Severe clinical manifestations, which require immediate referral

• Pregnancy

• Previous enrollment in the study within the last 28 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Uncomplicated Plasmodium Falciparum Malaria

Intervention

Device:
• Rapid diagnostic test for malaria
We used Paracheck Pf® (Orchid Biomedical Systems, India) as rapid diagnostic test in this trial

Locations

Country	Name	City	State
Tanzania	Villages	Kibaha	Kibaha District

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with fever prescribed artemether-lumefantrine for the treatment of malaria in respective study groups		28 days